Ficlatuzumab w/wo Cetuximab in Patients w/Cetuximab-Resistant, Recurrent or Metastatic Head/Neck … (NCT03422536) | Clinical Trial Compass
CompletedPhase 2
Ficlatuzumab w/wo Cetuximab in Patients w/Cetuximab-Resistant, Recurrent or Metastatic Head/Neck Squamous Cell Carcinoma
United States78 participantsStarted 2017-12-05
Plain-language summary
This randomized phase II trial studies how well ficlatuzumab with or without cetuximab works in treating patients with head and neck squamous cell carcinoma that has come back or spread to other places in the body and resistant to cetuximab treatment. Monoclonal antibodies, such as ficlatuzumab and cetuximab, may block growth signals that lets a tumor cell survive and reproduce, and helps the immune system recognize and fight head and neck squamous cell carcinoma.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
\- Patients must have histologically confirmed HNSCC from any primary site, except nasopharyngeal if World Health Organization (WHO) Type III (non-keratinizing and Epstein-Barr virus (EBV)-positive)).
Eligible histologies include:
* Basaloid, poorly differentiated, and undifferentiated carcinoma histologies.
* Nasopharyngeal carcinoma, WHO Type I and II (keratinizing, non-EBV positive).
* Paranasal sinus, lip and external auditory canal sites.
* Squamous cell carcinoma of unknown primary, clearly related to the head and neck.
Note: Documentation of primary site diagnosis must be submitted with the registration request.
* Patients must have recurrent and/or metastatic disease, fulfilling at least one of the criteria defined below:
* Incurable disease as assessed by surgical or radiation oncology;
* Metastatic (M1) disease;
* Persistent or progressive disease following curative-intent radiation, and not a candidate for surgical salvage due to incurability or morbidity. Note: Patients who decline radical surgery are eligible.
* For patients with oropharyngeal primary site or unknown primary site only: Patients must have known tumoral HPV status (p16). (Acceptable standards include p16 immunohistochemistry (where a tumor is classified as p16-positive when showing diffuse nuclear and cytoplasmic staining in at least 70% of tumor cells) and/or assessment of HPV DNA.) Note: For these subjects, documentation of p16 status must be submitted with the registrati…
What they're measuring
1
Progression Free Survival (PFS)
Timeframe: From the date of randomization until the date of progression or death, assessed up to 2 years